Core Courses:

Introduces the rational for, practical aspects of and new issues
in, drug and device development, as well as relevant industry and
government policies and regulations. Course topics include illness
targets, unmet medical need and the pharmaceutical life cycle,
scientific basis for drug development (e.g., drug discovery,
preclinical drug development and the patient studies including
pharmacology), protocol and budget preparation, phramacoeconomics
and quality of life, regulatory aspects, pharmacogenetics and
information technology, biotechnology and technology transfer, and
the role of academia in drug development.

This course explores federal policies and regulations related to
sponsored research and responsible conduct of clinical trials as
well as the design of institutional processes and systems for
assuring compliance. The focus in this course will be on the roles
and responsibilities of research administration and the oversight
of sponsored research and clinical trials.

This final project is meant to represent the culmination of
students’ experience in the program and must demonstrate mastery of
the curriculum and ability to conduct sustained independent
research and analysis. The project may be applied or may be a
traditional scholarly paper, in both cases a write-up following the
paper’s program-specific guidelines is required. Students must
submit a proposal and secure a first reader in order to register;
for further details students are advised to review the student
handbook and contact their academic advisor.

Elective Courses:

This course provides a comprehensive analysis of the fundamental
concepts and activities in the clinical research process. Emphasis
is on practical application of guidelines that govern clinical
research guidelines from sponsor and site perspectives and best
practices for clinical trial conduct, monitoring and financial
management. Topics include legal and ethical issues.